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

NCT03127995 | Active Not Recruiting DMC

• 2 other identifiers: UC-0107/16042016-A00702-49
• Study Type: interventional
• Target: 1,265
• Locations: 1 country
• Sites: 28

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

Conditions

Breast Cancer Female

Keywords

Breast Cancer pT1-3, pN0-N3, M0; Lymph Node Irradiation

Outcome Measures

Primary Outcomes (1)

• 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.

  At 3 years

Secondary Outcomes (11)

• Functional Assessment

  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

• Aesthetics Assessment-FIBROSIS

  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

• Aesthetics Assessment-BIS SCORE

  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

• Aesthetics Assessment-Global Cosmestic

  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

• CTCAE Toxicity Assessment

  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

Study Arms (2)

HYPOFRACTIONATED

EXPERIMENTAL

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

Radiation: HYPOFRACTIONATED

NORMOFRACTIONATED

OTHER

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

Radiation: NORMOFRACTIONATED

Interventions

HYPOFRACTIONATED RADIATION

40 Gy/ 15 fractions / 3 weeks

Also known as: Experimental Arm

HYPOFRACTIONATED

NORMOFRACTIONATED RADIATION

50 Gy/ 25 fractions / 5 weeks

Also known as: Standard Arm

NORMOFRACTIONATED

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICANCER: lead
• National Cancer Institute, France: collaborator

Study Sites (28)

Clinique de l'Europe

Amiens, 80090, France

Location

Institut de Cancerologie de L'Ouest-Paul Papin

Angers, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Hoptal Henri Mondor

Créteil, France

Location

Centre Georges Francois Leclerc

Dijon, France

Location

Centre Guillaume Le Conquerant

Le Havre, France

Location

Centre de radiothérapie Hartmann

Levallois-Perret, 92309, France

Location

Centre Galilée - Hôpital Privé La Louvière

Lille, 59800, France

Location

Centre Oscar Lambret

Lille, France

Location

Clinique Chenieux

Limoges, 87039, France

Location

Hôpital du Scorff

Lorient, 56100, France

Location

Centre Leon Berard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

Institut de Cancerologie de Lorraine

Nancy, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Saint-Louis

Paris, France

Location

Institut Curie

Paris, France

Location

Centre Eugene Marquis

Rennes, France

Location

Centre Henri Becquerel

Rouen, France

Location

Institut Curie- Rene Huguenin

Saint-Cloud, France

Location

Institut de Cancerologie de L'Ouest-Rene Gauducheau

Saint-Herblain, France

Location

Centre Paul Strauss

Strasbourg, France

Location

Institut Claudius Regaud

Toulouse, France

Location

CHU Bretonneau

Tours, 37044, France

Location

Gustave Roussy

Villejuif, France

Location

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Sofia RIVERA, M.D, Ph.D

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: April 25, 2017
• Study Start: September 1, 2016
• Primary Completion: December 31, 2022
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

FR (28)