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Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

Primary Purpose

Nasopharyngeal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Chemo + Low dose RT

Chemo alone

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

WHO II-III carcinoma of the nasopharynx, histologically proven.
Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases.
Age between 18 and 70 years.
ECOG performance status 0-2.
Hematological function parameters performed within 10 days before inclusion:
- Neutrophils ≥ 1000 * 109/l.
- Platelets: ≥ 100 * 109/l.
- Hemoglobin: ≥ 9 g/dl
Adequate hepatic function, defined as follows within 2 weeks prior to registration:
- Total bilirubin is normal
- AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center.
- Alkaline phosphatase <= 2.5 * ULN.
Renal function parameters performed within 10 days before inclusion: normal serum creatinine and creatinine clearance must be ≥ 55 ml/min.
Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

Patients who present stage I, IIa, IIb and IVc.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted;
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies.
Patients receiving other experimental therapeutic cancer treatment;
Blood pressure at baseline > 150/100 mmHg;
Peripheral neuropathy CTCAE, v. 4.0 h grade 2
Severe, active co-morbidity, defined as follows:
- Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy.
- Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug.
- Acquired Immune Deficiency.
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- Prior allergic reaction to the study drug(s) involved in this.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Chemo+RT low dose

B: Chemo alone

Arm Description

Chemo + Low dose RT: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin (CDDP) 75mg/m2 IV D1 and radiation therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for a total of 2 cycles every 21 days.

Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Outcomes

Primary Outcome Measures

Evaluation of chemo and radiation toxicities

Chemotherapy and acute radiation toxicities as evaluated using the revised NCI (CTCAE) Version 4.03

Secondary Outcome Measures

Distant and loco regional failure

Distant and loco regional failure as evaluated using Response Evaluation Criteria in Solid Tumors (RECIST)

Full Information

NCT ID

NCT03890185

First Posted

January 16, 2019

Last Updated

March 24, 2019

Sponsor

King Faisal Specialist Hospital & Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03890185

Brief Title

Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

Official Title

Randomized Phase II Trial of Docetaxal and Cisplatin Versus Low-Dose Fractionated Radiation Plus Docetaxal and Cisplatin as Induction Therapy in Locally Advanced Nasopharyngeal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2012 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King Faisal Specialist Hospital & Research Center

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

The central hypothesis is to test Low Dose Fraction Radiotherapy (LDFRT), as a potentiator of Docetaxel and Cisplatin efficacy in locally advanced nasopharyngeal cancer.

Detailed Description

Nasopharyngeal cancer is the commonest cancer of the head and neck in Saudi Arabia and constitutes nearly a half (44%) of all head and neck cancers diagnosed annually according to the National Cancer Registry Data. Majority of our patients present with locally advance disease which adversely affect their treatment outcome. The treatment of this disease has evolved over the last several years and several Phase III trials have now shown that combined chemotherapy and radiation are significantly superior to treatment with radiation therapy alone. However, results for treatment of the Stage III and IV disease remains less than satisfactory with a 5-year survival of 60-70 %. Recent data in other head and neck cancer sites including nasopharyngeal cancer indicates that the use of chemotherapy in combination with radiation may improve the outcome of therapy primarily by a reduction in the rate of distant metastasis. Induction chemotherapy alone has, however, failed to show an improvement in survival compared to radiation therapy alone. The administration of induction chemotherapy followed by concurrent chemo-radiation appears the most promising approach. Our experience at KFSH&RC with induction chemotherapy followed by chemo-radiation in Stage IV cancers, still reveals that approximately 25- 30% of patients will develop local relapse in the nasopharyngeal site; and 35- 40 % of patients are likely to develop distant metastasis. The most promising recent schedule of induction chemotherapy has been the use of Docetaxel and Cisplatin followed by concurrent Cisplatin and radiation. A recent Phase II study demonstrated that the three-year progression-free survival and overall survivals was improved with the use of this induction regimen. A variety of treatment strategies are currently being investigated in hope of achieving improved local control and enhanced survival of patients. These include addition of new chemotherapy drugs, other targeted agents such as Bevacizumab, Cetuximab, etc and radiation fractionation. The rationale for using neoadjuvant chemotherapy is that a reduction in the overall tumor burden will permit more effective local therapy and reduce the rates of distant metastases. Neoadjuvant cisplatin / docetaxel are active agents for locally advanced nasopharyngeal cancer. The addition of docetaxel to platinum containing neoadjuvant chemotherapy in other locally advanced head and neck squamous-cell carcinoma have also been shown to improve survival.

6. Conditions and Keywords

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

Nasopharyngeal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Chemo+RT low dose

Arm Type

Experimental

Arm Description

Arm Title

B: Chemo alone

Arm Type

Active Comparator

Arm Description

Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Intervention Type

Combination Product

Intervention Name(s)

Chemo + Low dose RT

Other Intervention Name(s)

Chemotherapy, Low Dose Radiation Therapy

Intervention Description

Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days.

Intervention Type

Drug

Intervention Name(s)

Chemo alone

Other Intervention Name(s)

Chemotherapy

Intervention Description

Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.

Primary Outcome Measure Information:

Title

Evaluation of chemo and radiation toxicities

Description

Chemotherapy and acute radiation toxicities as evaluated using the revised NCI (CTCAE) Version 4.03

Time Frame

Three years

Secondary Outcome Measure Information:

Title

Distant and loco regional failure

Description

Distant and loco regional failure as evaluated using Response Evaluation Criteria in Solid Tumors (RECIST)

Time Frame

Three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: WHO II-III carcinoma of the nasopharynx, histologically proven. Locally advanced stage III and IV (minimal intracranial extension only) with absence of distant metastases. Age between 18 and 70 years. ECOG performance status 0-2. Hematological function parameters performed within 10 days before inclusion: Neutrophils ≥ 1000 * 109/l. Platelets: ≥ 100 * 109/l. Hemoglobin: ≥ 9 g/dl Adequate hepatic function, defined as follows within 2 weeks prior to registration: Total bilirubin is normal AST (SGOT) and ALT (SGPT) <= 2.5 * upper limit of normal (ULN) of each center. Alkaline phosphatase <= 2.5 * ULN. Renal function parameters performed within 10 days before inclusion: normal serum creatinine and creatinine clearance must be ≥ 55 ml/min. Patient who has given his/her written consent before any specific procedure of the protocol. Exclusion Criteria: Patients who present stage I, IIa, IIb and IVc. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible); Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is permitted; Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. Head and neck surgery of the primary tumor or lymph nodes prior to registration, with the exception of incisional or excisional biopsies. Patients receiving other experimental therapeutic cancer treatment; Blood pressure at baseline > 150/100 mmHg; Peripheral neuropathy CTCAE, v. 4.0 h grade 2 Severe, active co-morbidity, defined as follows: Major medical or psychiatric illness, which in the investigators' opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy. Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months, or other cardiac compromise that in the judgment of the investigator will preclude the safe administration of a study drug. Acquired Immune Deficiency. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. Prior allergic reaction to the study drug(s) involved in this.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nasser Alrajhi, MD

Organizational Affiliation

King Faisal Specialist Hospital & Research Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC

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