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Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence (HYPOG-01)

Primary Purpose

Breast Cancer Female

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HYPOFRACTIONATED
NORMOFRACTIONATED
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer Female focused on measuring Breast Cancer pT1-3, pN0-N3, M0, Lymph Node Irradiation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status.
  • ECOG 0-2
  • Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN.
  • Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted.
  • The patient may be a candidate for a boost to the tumour bed.
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
  • Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery.
  • Primary systemic therapy of an operable breast cancer is accepted.
  • If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted.
  • Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated
  • Postoperative infection and/or seroma giving indication for drainage during RT is accepted
  • Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
  • Signed informed consent
  • Affiliated to the Social Security system

Exclusion Criteria:

  • Previous breast cancer or DCIS of the breast.
  • Bilateral breast cancer
  • Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
  • The patient has an indication for boost to 1 or more regional nodes
  • Previous radiotherapy to the chest region
  • Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial
  • Pregnant or lactating
  • Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.

Sites / Locations

  • Clinique de l'Europe
  • Institut de Cancerologie de L'Ouest-Paul Papin
  • Hôpital Jean Minjoz
  • Institut Bergonie
  • Centre Jean Perrin
  • Hoptal Henri Mondor
  • Centre Georges Francois Leclerc
  • Centre Guillaume Le Conquerant
  • Centre de radiothérapie Hartmann
  • Centre Galilée - Hôpital Privé La Louvière
  • Centre Oscar Lambret
  • Clinique Chenieux
  • Hôpital du Scorff
  • Centre Leon Berard
  • Institut Paoli Calmettes
  • ICM Val d'Aurelle
  • Institut de Cancerologie de Lorraine
  • Centre Antoine Lacassagne
  • Hopital Saint-Louis
  • Institut Curie
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Institut Curie- Rene Huguenin
  • Institut de Cancerologie de L'Ouest-Rene Gauducheau
  • Centre Paul Strauss
  • Institut Claudius Regaud
  • CHU Bretonneau
  • Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

HYPOFRACTIONATED

NORMOFRACTIONATED

Arm Description

40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: sequential boost with 40 Gy to CTV breast in 15 fractions and 16 Gy to CTV boost in 8 fractions or simultaneous integrated boost (SIB) with 42.3 Gy on CTV breast and 52.2 Gy on CTV boost in 18 fractions

50 Gy / 25 fractions, 2.0 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: sequential boost with 50 Gy to CTV breast in 25 fractions and 16 Gy to CTV boost in 8 fractions or simultaneous integrated boost (SIB) with 51.52 Gy on CTV breast and 63 Gy on CTV boost in 28 fractions

Outcomes

Primary Outcome Measures

Arm Lymphedema
Occurrence radiation-induced late morbidity measured as lymphedema of the arm on the treated side at 3 years after adjuvant radiotherapy as follows: At least≥ 10% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side relative to the baseline value, compared to the contralateral side circumference also relative to its baseline value.

Secondary Outcome Measures

Functional Assessment
Flexion/abduction of the upper arm will be assessed.
Aesthetics Assessment-FIBROSIS
Fibrosis as tissue induration, telangiectasia, oedema of the breast/chest wall and dyspigmentation will be evaluated according the LENT-SOMA scoring scale.
Aesthetics Assessment-BIS SCORE
The patient evaluates satisfaction on The Body Image Score (BIS) where has been added an extra question regarding clothing habits and furthermore based on the study by Lyngholm et al also 2 more questions regarding the satisfaction with the appearance of the treated breast after breast conservation with and without comparison to the opposite breast as done in the DBCG HYPOII trial. In addition, it will ask if the patient treated with breast conservation has had lipo-feeling injection in the breast during follow up.
Aesthetics Assessment-Global Cosmestic
The global cosmetic result after breast conservation will be based on Harris´ 4-point scale modified by Rune Gärtner et al
CTCAE Toxicity Assessment
Acute/ late toxicity will be assessed according to the flowchart and performed based on CTCAE V4
RTOG/EORTC Toxicity Assessment
Acute/ late toxicity will be assessed according to the flowchart and performed based on Toxicity Criteria of RTOG/EORTC
Cancer Related events
Cancer related endpoints are secondary endpoints in this trial. It's a composite outcome taking into account all relapse events (locoregional, invasive disease, distant disease), breast-cancer specific survival, and causes of death as defined per DATECAN guidelines. All time to cancer related endpoints are defined as starting from the date of randomization until the event.
Cost-Utility
A cost-utility analysis comparing radiotherapy regimens will be performed based on QALYs
Quality of Life QLQ-C30
Patients' quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Quality of Life EORTC BR23
Patients' quality of life will be assessed using self-administered questionnaire EORTC BR23
Quality of Life Euroqol EQ-5D5D
Patients' quality of life will be assessed using self-administered questionnaire Euroqol EQ-5D5D

Full Information

First Posted
December 15, 2016
Last Updated
February 3, 2023
Sponsor
UNICANCER
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT03127995
Brief Title
Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
Acronym
HYPOG-01
Official Title
Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
September 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks. Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women. The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Breast Cancer pT1-3, pN0-N3, M0, Lymph Node Irradiation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HYPOFRACTIONATED
Arm Type
Experimental
Arm Description
40 Gy / 15 fractions, 2.67 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: sequential boost with 40 Gy to CTV breast in 15 fractions and 16 Gy to CTV boost in 8 fractions or simultaneous integrated boost (SIB) with 42.3 Gy on CTV breast and 52.2 Gy on CTV boost in 18 fractions
Arm Title
NORMOFRACTIONATED
Arm Type
Other
Arm Description
50 Gy / 25 fractions, 2.0 Gy per fraction, 5 fractions per week. If the patient is candidate for a boost it will be provided as follows: sequential boost with 50 Gy to CTV breast in 25 fractions and 16 Gy to CTV boost in 8 fractions or simultaneous integrated boost (SIB) with 51.52 Gy on CTV breast and 63 Gy on CTV boost in 28 fractions
Intervention Type
Radiation
Intervention Name(s)
HYPOFRACTIONATED
Other Intervention Name(s)
Experimental Arm
Intervention Description
40 Gy/ 15 fractions / 3 weeks
Intervention Type
Radiation
Intervention Name(s)
NORMOFRACTIONATED
Other Intervention Name(s)
Standard Arm
Intervention Description
50 Gy/ 25 fractions / 5 weeks
Primary Outcome Measure Information:
Title
Arm Lymphedema
Description
Occurrence radiation-induced late morbidity measured as lymphedema of the arm on the treated side at 3 years after adjuvant radiotherapy as follows: At least≥ 10% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side relative to the baseline value, compared to the contralateral side circumference also relative to its baseline value.
Time Frame
At 3 years
Secondary Outcome Measure Information:
Title
Functional Assessment
Description
Flexion/abduction of the upper arm will be assessed.
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Aesthetics Assessment-FIBROSIS
Description
Fibrosis as tissue induration, telangiectasia, oedema of the breast/chest wall and dyspigmentation will be evaluated according the LENT-SOMA scoring scale.
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Aesthetics Assessment-BIS SCORE
Description
The patient evaluates satisfaction on The Body Image Score (BIS) where has been added an extra question regarding clothing habits and furthermore based on the study by Lyngholm et al also 2 more questions regarding the satisfaction with the appearance of the treated breast after breast conservation with and without comparison to the opposite breast as done in the DBCG HYPOII trial. In addition, it will ask if the patient treated with breast conservation has had lipo-feeling injection in the breast during follow up.
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Aesthetics Assessment-Global Cosmestic
Description
The global cosmetic result after breast conservation will be based on Harris´ 4-point scale modified by Rune Gärtner et al
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
CTCAE Toxicity Assessment
Description
Acute/ late toxicity will be assessed according to the flowchart and performed based on CTCAE V4
Time Frame
Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
RTOG/EORTC Toxicity Assessment
Description
Acute/ late toxicity will be assessed according to the flowchart and performed based on Toxicity Criteria of RTOG/EORTC
Time Frame
Before treatment, every week of treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Cancer Related events
Description
Cancer related endpoints are secondary endpoints in this trial. It's a composite outcome taking into account all relapse events (locoregional, invasive disease, distant disease), breast-cancer specific survival, and causes of death as defined per DATECAN guidelines. All time to cancer related endpoints are defined as starting from the date of randomization until the event.
Time Frame
6 months after the last fraction received, every year during 5 years, 10 years
Title
Cost-Utility
Description
A cost-utility analysis comparing radiotherapy regimens will be performed based on QALYs
Time Frame
Week 3 or week 7 of treatment according the treatment arm and boost realization
Title
Quality of Life QLQ-C30
Description
Patients' quality of life will be assessed using self-administered questionnaire EORTC QLQ-C30
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Quality of Life EORTC BR23
Description
Patients' quality of life will be assessed using self-administered questionnaire EORTC BR23
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years
Title
Quality of Life Euroqol EQ-5D5D
Description
Patients' quality of life will be assessed using self-administered questionnaire Euroqol EQ-5D5D
Time Frame
Before treatment, week 3 or week 7 of treatment according the treatment arm and boost realization, 6 months after the last fraction received, every year during 5 years, 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Woman ≥ 18 years who had radical surgery for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of oestrogen receptor, progesterone receptor, malignancy grade, HER2 status. ECOG 0-2 Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiotherapy to levels +/-I, +/- II, +/-III, +/-IV, +/-interpectoral nodes (Rötter) and +/-the IMN. Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines are accepted. The patient may be a candidate for a boost to the tumour bed. Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted. Neoadjuvant chemotherapy for downstaging according to institutional or national guidelines is accepted if there is not an indication for a boost in the area of regional nodes after surgery. Primary systemic therapy of an operable breast cancer is accepted. If the patient is not treated with chemotherapy, the patient must be randomized within 8 weeks from last surgery. If the patient has received adjuvant chemotherapy, the patient must be randomized within 4 weeks after the last series of adjuvant chemotherapy or within 42 days from last surgery in case of surgery after neoadjuvant or adjuvant chemotherapy.Breast implants are accepted. Connective tissue disease is allowed if the treating radiation oncologist finds radiotherapy indicated Postoperative infection and/or seroma giving indication for drainage during RT is accepted Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy Signed informed consent Affiliated to the Social Security system Exclusion Criteria: Previous breast cancer or DCIS of the breast. Bilateral breast cancer Patient with previous non-breast malignancy with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin The patient has an indication for boost to 1 or more regional nodes Previous radiotherapy to the chest region Patient enrolled in another therapeutic trial. Observational cohorts are accepted if the collection of data does not interfere with the current trial Pregnant or lactating Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating radiation oncologist thinks the patient should not participate in the trial for example due to language problems.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia RIVERA, M.D, Ph.D
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de l'Europe
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
Institut de Cancerologie de L'Ouest-Paul Papin
City
Angers
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
Hoptal Henri Mondor
City
Creteil
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon
Country
France
Facility Name
Centre Guillaume Le Conquerant
City
Le Havre
Country
France
Facility Name
Centre de radiothérapie Hartmann
City
Levallois-Perret
ZIP/Postal Code
92309
Country
France
Facility Name
Centre Galilée - Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59800
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Clinique Chenieux
City
Limoges
ZIP/Postal Code
87039
Country
France
Facility Name
Hôpital du Scorff
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Institut de Cancerologie de Lorraine
City
Nancy
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
Country
France
Facility Name
Institut Curie
City
Paris
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Institut Curie- Rene Huguenin
City
Saint-Cloud
Country
France
Facility Name
Institut de Cancerologie de L'Ouest-Rene Gauducheau
City
Saint-Herblain
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence

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