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NCT Number: NCT02735057

Chemoradiotherapy in Elderly Patients With Oesophagus Cancer

Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.

Chemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.

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Key information

Conditions

Oesophagus Cancer Digestive System Diseases Digestive System Neoplasms Elderly Patients Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

75 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location status: Recruiting

Location contact

Elise ROBERT

CONTACT

[email protected]

Jihane BOUSTANI, PH

PRINCIPAL_INVESTIGATOR

About this study

Choice of the combined chemotherapy Carboplatin and taxanes delivered concurrently to radiotherapy is attractive. A Dutch randomized study (Cross trial) compared preoperative CRT to surgery in 368 patients with T1-T3 and N0N1. In the preoperative CRT group, patients received 41.4 Gy by EBRT over 5 weeks combined with carboplatin (AUC 2) and paclitaxel (50 mg/m2). A 30 % tumor sterilization rate and a reduction of metastasis considered a distant effect of chemotherapy were observed. The 5-year survival was statistically better with CRT group. The preoperative CRT was well tolerated and few acute toxicities were observed. Intriguingly, in a French randomized study, conducted in less locally advanced disease, the combination of 45 Gy and 5 FU infusion and Cisplatin did not induce more tumor sterilization rate, suggesting carboplatine/paclitaxel is more effective than 5FU/cisplatin in CRT.

Study design Since the optimal doses of each component radiotherapy- carboplatin - paclitaxel are unknown, we plan to conduct a phase I/II study

  • Phase I: the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II (RP2D) of each component considering the treatment scheme of Dutch study as reference:
  • for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg/m2)
  • for radiotherapy 3 levels: 41.4 Gy/1.8 Gy/f; 45 Gy/1.8 Gy/f; 50.4 Gy/1.8 Gy/f basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.
  • Phase II: after the determination of RP2D of each component, the study is continued as a phase II in order to assess tumor response Secondary objectives: Quality of life, progression free and overall survivals

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),
  • age > 75 years,
  • WHO status < 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.

Exclusion criteria

  • age < 75 years

Treatment and study plan

carboplatin

Drug

Other names: Paclitaxel

Primary outcomes

  1. maximum tolerated dose (MTD)

    Time frame: 1 months after the end of the treatment

    the objective is to determine the maximum tolerated dose (MTD) and recommended doses for phase II.The phase I is conducted with increasing doses of each component with 9 levels.Step definitively stopped in case of any grade ≥ 3 or severe acute toxicities. In case a step is definitively stopped, add 3 more patients to the precedent step.

    Quality assurance

Secondary outcomes

  1. Quality of life

    Time frame: 3 years

    EORTC QLQ-C30,

  2. Quality of life

    Time frame: 3 years

    ELD14

  3. progression free survival

    Time frame: 3 years

  4. overall survival

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane BOUSTANI, Dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer

Acronym: OSAGE

Important dates

Study start
2016
Primary completion
2028
Study completion
2029
First posted
Apr 12, 2016
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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