Back to results

Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer (ACCRAPAN)

Primary Purpose

Locally Advanced Cancer, Cervical Cancer

Status

Active

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Carboplatin-Paclitaxel adjuvant chemotherapy

About this trial

This is an interventional treatment trial for Locally Advanced Cancer focused on measuring Adjuvant Chemotherapy, Cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

PART 1:

Inclusion Criteria:

Female patient aged more than 18 years old
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
With locally advanced cervical cancer (FIGO stage IIIC2)
With para-aortic or iliac common nodes positive on PET-scan or after laparoscopic surgical staging if PET-scan negative
ECOG Performance Status ≤ 2
Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL
Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m²
Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease)
Negative serum pregnancy test within 7 days prior to treatment for women of childbearing potential. For non-menopaused women, if not surgically sterilized, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment
Absence of contraindication to receive the products used in this study (products used in concomitant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/)
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
Patient covered by the French "Social Security" regime
Signed informed consent form

Exclusion Criteria:

Histological diagnosis of sarcoma
Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy,
Presence of distant metastases other than lombo-aortic lymph nodes
Patient with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
Patient with bilateral hydronephrosis unless at least one side has been stented
Prior diagnosis of Crohn's disease or ulcerative colitis or sclerodermia
Other uncontrolled intercurrent disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
Pregnant or breastfeeding woman,
Participation in another therapeutic trial with an experimental molecule for the current disease
Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
Person under guardianship or curatorship

PART 2:

Inclusion Criteria:

Maintained consent
Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL
Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m2
Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease)
Patient having received curative intent chemo-radiation therapy with the following recommendations:
- extended field CT-RT delivered by IMRT: 45-50Gy according the dosimetry limitation histogram dose volume (HDV) in whole pelvis and Para Aortic volumes + concomitant boost on macroscopic nodes defined as PET-positive
- associated with weekly Cisplatin (40mg/m²)
- followed by image guided brachytherapy. Patient will be eligible even in case of temporary stop of radiation therapy, provided she has received a total dose of 45Gy and a concomitant boost. Patient should have received at least 3 injections of Cisplatin 40mg/m² during radiation therapy.

Exclusion Criteria:

Progression during Part 1,
Contraindication for one of the study drug in particular the residual toxicity of Part 1 (radio-chemotherapy) such as:
- Renal failure (defined as creatinine clearance according to MDRD formula < 60 mL/ min/1.73m2),
- Any clinical residual toxicity (including peripheral neuropathy) ≥ grade 2 (as per CTCAE v5),
Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received)
Cumulative dose of Cisplatin received less than 120 mg/m².

Sites / Locations

Centre Marie Curie
Centre Pierre Curie
Centre Léonard de Vinci
Centre Hospitalier de Lens
Centre Oscar Lambret
Clinique des dentellières

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin-Paclitaxel adjuvant chemotherapy

Arm Description

Patients will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment).

Outcomes

Primary Outcome Measures

Progression Free Survival with adjuvant chemotherapy

To evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years. Progression will be evaluated with RECIST criteria v1.1. The main analysis of this phase II trial will focus on the 2-year PFS rate from inclusion in the Part 2, but the whole curve will be estimated.

Secondary Outcome Measures

Overall Survival with adjuvant chemotherapy

To evaluate efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel in terms of Overall Survival (OS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. OS will be estimated with the Kaplan-Meier method.

Metastasis Free Survival with adjuvant chemotherapy

To evaluate efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel in terms of Metastasis Free Survival (MFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. Metastatic progressions will be evaluated with the RECIST criteria.

Number of Cycles Received of adjuvant chemotherapy

To describe feasibility of adjuvant chemotherapy in terms of number of cycles received, separately for each molecule Carboplatin and Paclitaxel. The number of cycles will be recorded in the data base with the date and doses of injections, allowing the calculation of the Relative Dose Intensity. Reasons of treatment stop or dose modification will also be recorded.

Progression Free Survival with concomitant chemo-radiotherapy associated to brachytherapy

To evaluate the efficacy of adjuvant chemotherapy with concomitant chemo-radiotherapy associated to brachytherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. Progression will be based on a MRI scan, done during the usual oncologic follow-up: every 3 months during the 2 first years after radio-chemotherapy, and then every 6 months during 3 years. Progression will be evaluated with RECIST criteria v1.1.

Overall Survival with concomitant chemo-radiotherapy associated to brachytherapy

To evaluate efficacy of concomitant chemo-radiotherapy associated to brachytherapy in terms of Overall Survival (OS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. OS will be estimated with the Kaplan-Meier method.

Metastasis Free Survival with concomitant chemo-radiotherapy associated to brachytherapy

To evaluate efficacy of concomitant chemo-radiotherapy associated to brachytherapy in terms of Metastasis Free Survival (MFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes. Metastatic progressions will be evaluated with the RECIST criteria.

Number of Cycles Received of concomitant chemo-radiotherapy associated to brachytherapy

To describe feasibility of the concomitant chemo-radiotherapy associated to brachytherapy (Part 1 of the study) in terms of number of cycles received. The number of cycles will be recorded in the data base with the date and doses of injections, allowing the calculation of the Relative Dose Intensity. Reasons of treatment stop or dose modification will also be recorded.

Safety of the whole treatment

To describe safety of the whole treatment (part 1 & 2) in terms of Adverse Event. During the first part of the study (concomitant radio-chemotherapy), all AE (Adverse Events) will be reported. AE occurring after end of treatment will not be collected for patients withdrawn from the study at the end of the first part. For the second part of the study (adjuvant chemotherapy), all AE will be reported up to 30 days after the end of adjuvant chemotherapy, until progression if any. Then, only AE possibly related to chemotherapy or radiation therapy will be collected, up to 5 years after the end of radiation therapy or until progression (whichever occurs first). All AE will be graded using the NCI-CTCAE v5.0 and AE of grade >2 will be considered as severe AE.

Full Information

NCT ID

NCT04016142

First Posted

May 31, 2019

Last Updated

September 7, 2023

Sponsor

Centre Oscar Lambret

1. Study Identification

Unique Protocol Identification Number

NCT04016142

Brief Title

Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer

Acronym

ACCRAPAN

Official Title

Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 15, 2020 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes. Patients will be registered in the first part of the study at diagnosis and will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage (no progression during Part 1 of the study and no medical contra-indication to the study treatment). The primary objective is to evaluate the efficacy of adjuvant chemotherapy with Carboplatin-Paclitaxel administrated in adjuvant situation after concomitant radio-chemotherapy in terms of Progression Free Survival (PFS) in patients treated for a locally advanced cervical cancer presenting positive lombo-aortic lymph nodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Cancer, Cervical Cancer

Keywords

Adjuvant Chemotherapy, Cervical cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carboplatin-Paclitaxel adjuvant chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Carboplatin-Paclitaxel adjuvant chemotherapy

Other Intervention Name(s)

Adjuvant Chemotherapy, Carboplatin-Paclitaxel

Intervention Description

Patients will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, "Part 1 of the study"). Then, they will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, "Part 2 of the study"), providing they fulfill eligibility criteria at this stage. The second part consists in 4 cycles of Carboplatin-Paclitaxel adjuvant chemotherapy (one cycle = 3 weeks of treatment and 1 free-week)

Primary Outcome Measure Information:

Title

Progression Free Survival with adjuvant chemotherapy

Description

Time Frame

From the date of inclusion in the Part 2 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 64 months.

Secondary Outcome Measure Information:

Title

Overall Survival with adjuvant chemotherapy

Description

Time Frame

From the date of inclusion in the Part 2 of the study until the date of death whatever the cause. Assessed up to 64 months.

Title

Metastasis Free Survival with adjuvant chemotherapy

Description

Time Frame

From the date of inclusion in the Part 2 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 64 months.

Title

Number of Cycles Received of adjuvant chemotherapy

Description

Time Frame

From the date of inclusion in the Part 2 of the study until the date of adjuvant chemotherapy ending or patient study output or death whatever the cause. Up to 4 months.

Title

Progression Free Survival with concomitant chemo-radiotherapy associated to brachytherapy

Description

Time Frame

From the date of inclusion in the Part 1 of the study until the date of first progression or relapse (local, lymph nodes or metastatic) or death whatever the cause. Assessed up to 67 months.

Title

Overall Survival with concomitant chemo-radiotherapy associated to brachytherapy

Description

Time Frame

From the date of inclusion in the Part 1 of the study until the date of death whatever the cause. Assessed up to 67 months.

Title

Metastasis Free Survival with concomitant chemo-radiotherapy associated to brachytherapy

Description

Time Frame

From the date of inclusion in the Part 1 of the study until the date of first metastatic progression or death whatever the cause. Assessed up to 67 months.

Title

Number of Cycles Received of concomitant chemo-radiotherapy associated to brachytherapy

Description

Time Frame

From the date of inclusion in the Part 1 of the study until the date of concomitant chemo-radiotherapy associated to brachytherapy ending or patient study output or death whatever the cause. Assessed up to 12 weeks.

Title

Safety of the whole treatment

Description

Time Frame

From the date of inclusion in the Part 1 of the study, up to 5 years after the end of radiation therapy or until progression (whichever occurs first).

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Patient has to suffer from a cervical cancer.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

PART 1: Inclusion Criteria: Female patient aged more than 18 years old Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix With locally advanced cervical cancer (FIGO stage IIIC2) With para-aortic or iliac common nodes positive on PET-scan or after laparoscopic surgical staging if PET-scan negative ECOG Performance Status ≤ 2 Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m² Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease) Negative serum pregnancy test within 7 days prior to treatment for women of childbearing potential. For non-menopaused women, if not surgically sterilized, willing to accept the use of an effective contraceptive regimen during the treatment period and at least 6 months after the end of treatment Absence of contraindication to receive the products used in this study (products used in concomitant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/) Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up Patient covered by the French "Social Security" regime Signed informed consent form Exclusion Criteria: Histological diagnosis of sarcoma Previous hysterectomy or planned hysterectomy as part of their initial cervix cancer therapy, Presence of distant metastases other than lombo-aortic lymph nodes Patient with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years Patient with bilateral hydronephrosis unless at least one side has been stented Prior diagnosis of Crohn's disease or ulcerative colitis or sclerodermia Other uncontrolled intercurrent disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation Pregnant or breastfeeding woman, Participation in another therapeutic trial with an experimental molecule for the current disease Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons) Person under guardianship or curatorship PART 2: Inclusion Criteria: Maintained consent Adequate hematologic function: Absolute Neutrophil Count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 10g/dL Adequate renal function: creatinine clearance (estimated according to MDRD formula) ≥ 60ml/min/1.73m2 Adequate hepatic function: Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤ 2.5 × upper normal limit (UNL); Total bilirubin ≤ 1.5 x UNL (except in case of Gilbert's disease) Patient having received curative intent chemo-radiation therapy with the following recommendations: extended field CT-RT delivered by IMRT: 45-50Gy according the dosimetry limitation histogram dose volume (HDV) in whole pelvis and Para Aortic volumes + concomitant boost on macroscopic nodes defined as PET-positive associated with weekly Cisplatin (40mg/m²) followed by image guided brachytherapy. Patient will be eligible even in case of temporary stop of radiation therapy, provided she has received a total dose of 45Gy and a concomitant boost. Patient should have received at least 3 injections of Cisplatin 40mg/m² during radiation therapy. Exclusion Criteria: Progression during Part 1, Contraindication for one of the study drug in particular the residual toxicity of Part 1 (radio-chemotherapy) such as: Renal failure (defined as creatinine clearance according to MDRD formula < 60 mL/ min/1.73m2), Any clinical residual toxicity (including peripheral neuropathy) ≥ grade 2 (as per CTCAE v5), Radiation therapy prematurely stopped (total dose on whole pelvis and on nodes not received) Cumulative dose of Cisplatin received less than 120 mg/m².

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florence Le Tinier, MD

Organizational Affiliation

Centre Oscar Lambret

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Marie Curie

City

Arras

Country

France

Facility Name

Centre Pierre Curie

City

Beuvry

Country

France

Facility Name

Centre Léonard de Vinci

City

Dechy

Country

France

Facility Name

Centre Hospitalier de Lens

City

Lens

Country

France

Facility Name

Centre Oscar Lambret

City

Lille

Country

France

Facility Name

Clinique des dentellières

City

Valenciennes

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16705366

Citation

Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. doi: 10.1007/s10549-006-9254-4. Epub 2006 May 17.

Results Reference

background

PubMed Identifier

19001332

Citation

Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10.

Results Reference

background

PubMed Identifier

22554549

Citation

Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6.

Results Reference

background

PubMed Identifier

17258799

Citation

Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. doi: 10.1016/j.ygyno.2006.12.012. Epub 2007 Jan 29.

Results Reference

background

PubMed Identifier

18694852

Citation

Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8(1):146-55. doi: 10.1102/1470-7330.2008.0022.

Results Reference

background

PubMed Identifier

15050330

Citation

Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12. doi: 10.1016/j.ijrobp.2003.09.013.

Results Reference

background

PubMed Identifier

15380585

Citation

Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12. doi: 10.1016/j.ijrobp.2004.03.035.

Results Reference

background

PubMed Identifier

7616634

Citation

Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.

Results Reference

background

PubMed Identifier

14990643

Citation

Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80. doi: 10.1200/JCO.2004.07.197.

Results Reference

background

PubMed Identifier

10202164

Citation

Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.

Results Reference

background

PubMed Identifier

11704321

Citation

Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7. doi: 10.1016/s0360-3016(01)01723-0.

Results Reference

background

PubMed Identifier

12873680

Citation

Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60. doi: 10.1016/s0360-3016(03)00325-0.

Results Reference

background

PubMed Identifier

24661323

Citation

Cihoric N, Tapia C, Kruger K, Aebersold DM, Klaeser B, Lossl K. IMRT with (1)(8)FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.

Results Reference

background

PubMed Identifier

25303889

Citation

Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.

Results Reference

background

PubMed Identifier

24552890

Citation

Perry LJ, Mathews C, Nugent E, Farrell R, Zorn K, Moore K. Outcomes of cervical cancer and positive para-aortic lymph nodes in the modern era of chemoradiation. Int J Gynecol Cancer. 2014 Mar;24(3):564-9. doi: 10.1097/IGC.0000000000000093.

Results Reference

background

PubMed Identifier

23857967

Citation

Gouy S, Morice P, Narducci F, Uzan C, Martinez A, Rey A, Bentivegna E, Pautier P, Deandreis D, Querleu D, Haie-Meder C, Leblanc E. Prospective multicenter study evaluating the survival of patients with locally advanced cervical cancer undergoing laparoscopic para-aortic lymphadenectomy before chemoradiotherapy in the era of positron emission tomography imaging. J Clin Oncol. 2013 Aug 20;31(24):3026-33. doi: 10.1200/JCO.2012.47.3520. Epub 2013 Jul 15.

Results Reference

background

PubMed Identifier

21444871

Citation

Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28.

Results Reference

background

PubMed Identifier

19268342

Citation

Mabuchi S, Morishige K, Fujita M, Tsutsui T, Sakata M, Enomoto T, Kimura T. The activity of carboplatin and paclitaxel for recurrent cervical cancer after definitive radiotherapy. Gynecol Oncol. 2009 May;113(2):200-4. doi: 10.1016/j.ygyno.2009.02.008. Epub 2009 Mar 6.

Results Reference

background

PubMed Identifier

15904950

Citation

Tinker AV, Bhagat K, Swenerton KD, Hoskins PJ. Carboplatin and paclitaxel for advanced and recurrent cervical carcinoma: the British Columbia Cancer Agency experience. Gynecol Oncol. 2005 Jul;98(1):54-8. doi: 10.1016/j.ygyno.2005.03.037.

Results Reference

background

PubMed Identifier

20613898

Citation

Mabuchi S, Morishige K, Enomoto T, Kimura T. Carboplatin and paclitaxel as an initial treatment in patients with stage IVb cervical cancer: a report of 7 cases and a review of the literature. J Gynecol Oncol. 2010 Jun;21(2):93-6. doi: 10.3802/jgo.2010.21.2.93. Epub 2010 Jun 30.

Results Reference

background

PubMed Identifier

14602133

Citation

Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Eur J Cancer. 2003 Nov;39(17):2470-86. doi: 10.1016/s0959-8049(03)00425-8.

Results Reference

background

PubMed Identifier

23695016

Citation

McCormack M, Kadalayil L, Hackshaw A, Hall-Craggs MA, Symonds RP, Warwick V, Simonds H, Fernando I, Hammond M, James L, Feeney A, Ledermann JA. A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer. Br J Cancer. 2013 Jun 25;108(12):2464-9. doi: 10.1038/bjc.2013.230. Epub 2013 May 21.

Results Reference

background

PubMed Identifier

18420499

Citation

Sparano JA, Wang M, Martino S, Jones V, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Weekly paclitaxel in the adjuvant treatment of breast cancer. N Engl J Med. 2008 Apr 17;358(16):1663-71. doi: 10.1056/NEJMoa0707056. Erratum In: N Engl J Med. 2008 Jul 3;359(1):106. N Engl J Med. 2009 Apr 16;360(16):1685.

Results Reference

background

PubMed Identifier

13726497

Citation

ELLIS RE. The distribution of active bone marrow in the adult. Phys Med Biol. 1961 Jan;5:255-8. doi: 10.1088/0031-9155/5/3/302. No abstract available.

Results Reference

background

PubMed Identifier

9809875

Citation

Vande Berg BC, Malghem J, Lecouvet FE, Maldague B. Magnetic resonance imaging of the normal bone marrow. Skeletal Radiol. 1998 Sep;27(9):471-83. doi: 10.1007/s002560050423.

Results Reference

background

PubMed Identifier

22974331

Citation

Platta CS, Bayliss A, McHaffie D, Tome WA, Straub MR, Bradley KA. A dosimetric analysis of tomotherapy based intensity modulated radiation therapy with and without bone marrow sparing in gynecologic malignancies. Technol Cancer Res Treat. 2013 Feb;12(1):19-29. doi: 10.7785/tcrt.2012.500300. Epub 2012 Sep 10.

Results Reference

background

PubMed Identifier

16757127

Citation

Mell LK, Kochanski JD, Roeske JC, Haslam JJ, Mehta N, Yamada SD, Hurteau JA, Collins YC, Lengyel E, Mundt AJ. Dosimetric predictors of acute hematologic toxicity in cervical cancer patients treated with concurrent cisplatin and intensity-modulated pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2006 Dec 1;66(5):1356-65. doi: 10.1016/j.ijrobp.2006.03.018. Epub 2006 Jun 6.

Results Reference

background

PubMed Identifier

26844613

Citation

Chang Y, Yang ZY, Li GL, Li Q, Yang Q, Fan JQ, Zhao YC, Song YQ, Wu G. Correlations Between Radiation Dose in Bone Marrow and Hematological Toxicity in Patients With Cervical Cancer: A Comparison of 3DCRT, IMRT, and RapidARC. Int J Gynecol Cancer. 2016 May;26(4):770-6. doi: 10.1097/IGC.0000000000000660.

Results Reference

background

PubMed Identifier

25304718

Citation

Yang TJ, Oh JH, Apte A, Son CH, Deasy JO, Goodman KA. Clinical and dosimetric predictors of acute hematologic toxicity in rectal cancer patients undergoing chemoradiotherapy. Radiother Oncol. 2014 Oct;113(1):29-34. doi: 10.1016/j.radonc.2014.09.002. Epub 2014 Oct 7.

Results Reference

background

PubMed Identifier

12957265

Citation

Lujan AE, Mundt AJ, Yamada SD, Rotmensch J, Roeske JC. Intensity-modulated radiotherapy as a means of reducing dose to bone marrow in gynecologic patients receiving whole pelvic radiotherapy. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):516-21. doi: 10.1016/s0360-3016(03)00521-2.

Results Reference

background

PubMed Identifier

20472347

Citation

Lim K, Small W Jr, Portelance L, Creutzberg C, Jurgenliemk-Schulz IM, Mundt A, Mell LK, Mayr N, Viswanathan A, Jhingran A, Erickson B, De los Santos J, Gaffney D, Yashar C, Beriwal S, Wolfson A, Taylor A, Bosch W, El Naqa I, Fyles A; Gyn IMRT Consortium. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic radiotherapy for the definitive treatment of cervix cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):348-55. doi: 10.1016/j.ijrobp.2009.10.075. Epub 2010 May 14.

Results Reference

background

PubMed Identifier

11252008

Citation

A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

Results Reference

background

Learn more about this trial

Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical Cancer

We'll reach out to this number within 24 hrs