Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy

Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy

Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy

Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy

Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy

Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy

Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles

Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles

Adjuvant chemotherapy using PF (5-Fluorouracil )

Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles

Induction chemotherapy using PF (5-Fluorouracil)

Anne W.M. Lee, F.R.C.R.

Roger K.C. Ngan, F.R.C.R

The objectives of this clinical study are threefold:

1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

1. primary objectives include

   1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
   2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
   3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
2. secondary objectives include

   1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
   2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma

The Hong Kong Anti-Cancer Society

hong Kong Cancer Fund

Hong Kong Nasopharyngeal Cancer Study Group Limited

Consultant, Dept of Clinical Oncology, PYNEH

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Squamous Cell

Laryngeal Diseases

Laryngeal Cancer

Valentina B Krstevska

The aim of our study was to evaluate the value of two different altered fractionation schedules - hyperfractionation and accelerated fractionation with concomitant boost - in comparison with conventional fractionation in primary definitive radiotherapy for squamous cell carcinomas of the larynx, oropharynx or hypopharynx. The study began and was conducted while the only teletherapy unit in our department was the cobalt-60 machine. During that period we were expecting the installation of new sophisticated equipment. We assumed that the results of this study would be also able to show whether or not it would be rational to use the altered fractionation regimens on the new machines.

Eligible patients admitted from March 1999 to December 2000 were treated with conventionally fractionated radiotherapy. These patients represented the retrospective part of the study. Patients admitted between January 2001 and June 2004 were included in the prospective part of the study. Following the confirmation of their eligibility, altered fractionation schedule assignment was made after stratifying by site of origin (larynx vs oropharynx vs hypopharynx), Karnofsky performance score (60%-70% vs 80%-100%), and stage of disease (I and II vs III and IV). Patients were randomized to receive radiotherapy delivered using either hyperfractionation or accelerated fractionation with concomitant boost as a late accelerating component. Exceptions occurred when patients either refused treatment with two daily fractions or were not offered twice-a-day irradiation because of lack of machine time.

Radiotherapy Scheduling and Technique The conventionally fractionated radiotherapy schedule was 66-70 Gy in 6½ -7 weeks (one fraction of 2 Gy per day, 5 fractions per week), whereas the hyperfractionation treatment schedule was 74.4-79.2 Gy in 6.2-7 weeks (two fractions of 1.2 Gy per day, 10 fractions per week with interfraction interval of at least 6 hours; Figure 1). The treatment schedule in accelerated fractionation using concomitant boost consisted of daily fraction of 1.8 Gy, 5 days a week, up to 32.4 Gy including all sites of disease and electively irradiated areas of the neck, followed by two daily fractions for the last 11-12 days. The first daily fraction encompassed all sites of the disease and electively irradiated neck nodes using a dose of 1.8 Gy, and the second daily fraction was the concomitant boost delivered through reduced fields to encompass the gross disease only, using a fraction of 1.5 Gy up to total doses of 68.7-72 Gy in 6 weeks (Figure 1). The interval between the two daily fractions was at least 6 hours.

Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer

Hyperfractionation and Accelerated Fractionation in Comparison With Conventional Fractionation in Definitive Radiotherapy of Squamous Cell Carcinoma of Larynx, Oropharynx and Hypopharynx

Institute of Radiotherapy and Oncology, Macedonia

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

radiotherapy with conventional fractionation (5 x 2Gy per week)

radiotherapy with accelerated fraction (7 x 2 Gy per week)

In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.

conventional fractionation

In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.

accelerated fraction

Rebecca Bütof, Dr.

In this randomized multicentric phase II study it will be investigated whether an accelerated postoperative radiotherapy with photons or protons (7 fractions per week, 2 Gy single dose) may improve locoregional tumour control in non-small cell lung cancer (NSCLC) in comparison to conventional fractionation (5 fractions per week, 2 Gy single dose).

This study is a randomized multicentric trial. Within this study an accelerated irradiation schedule (7 fractions per week, 2 Gy single dose) will be compared with the currently used conventional fractionation schedule (5 fractions per week, 2 Gy single dose) for postoperative radiotherapy with photons or protons in patients with NSCLC. The primary endpoint is locoregional tumour control after 36 months. Secondary endpoints are overall survival of patients, local recurrence-free and distant metastases-free survival after 36 months, acute and late toxicity as well as quality of life for both treatment methods.

Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation

Local tumor control will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).

Follow-up visits should be continued in all patients until death. Otherwise patients will be censored with date of the last follow-up.

Local-recurrences will be assessed by appropriate non-invasive (CT or PET-CT) and if necessary invasive examination methods (bronchoscopy with biopsy).

The occurrence of acute side effects (up to 90 days after start of treatment) will be recorded and documented based on CTCAE 4.0.

The assessment of quality of life is carried out using the established EORTC QLQ-C30 questionnaire and the additional lung module QLQ-LC13. Quality of life will be documented immediately before the start of therapy, after completion of postoperative radiotherapy and at every follow-up visit.

Distant metastases will be assessed by PET-CT or abdominal sonography and chest x-ray.

The occurrence of late side effects will be recorded and documented based on CTCAE 4.0 after every follow-up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma	NCT00379262	Nasopharyngeal ...	Capecitabine Adjuvant chemot... Induction chemo...	18 Years - 70 Years	Hong Kong Nasopharyngeal Cancer Study Group Limited
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma	NCT00379262	Nasopharyngeal ...	Capecitabine Adjuvant chemot... Induction chemo...	18 Years - 70 Years	Hong Kong Nasopharyngeal Cancer Study Group Limited
Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer	NCT00291434	Head and Neck C...		18 Years - 75 Years	Institute of Radiotherapy and Oncology, Macedonia
Altered and Conventional Fractionated Radiotherapy in Patients With Head and Neck Cancer	NCT00291434	Head and Neck C...		18 Years - 75 Years	Institute of Radiotherapy and Oncology, Macedonia
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden
Postoperative Radiotherapy of Non-small Cell Lung Cancer: Accelerated vs. Conventional Fractionation	NCT02189967	Non-Small Cell ...	conventional fr... accelerated fra...	18 Years -	Technische Universität Dresden

Spots Global Cancer Trial Database for accelerated fractionation